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Terminated

Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758

FDA Recall Z-1010-04 · Posted 2004-07-20

Recalling FirmEncore Medical, LP
Recall StatusTerminated
Product CodeJWH
Date Initiated2004-05-10
Date Terminated2004-08-09
Product Quantity15

Reason for Recall

Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE

Firm Action

The firm sent recall letters to all consignees on May 10, 2004 requesting return of the product.

Root Cause

Other

Distribution Pattern

Product was distributed domesically to the following states: IA, MA, OK, TX, FL, CA, and SD. Product was shipped to one distributor in Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K923277FOUNDATION KNEE SYSTEMEncore Orthopedics, Inc. · 1993-02-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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